Epogen and Anemia-Less is More

November 17, 2006

Singh AK et al. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 2006 Nov 16; 355:2085-98.

Drüeke TB et al. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med 2006 Nov 16; 355:2071-84.

It’s always been unclear what target hgb we should be shooting for in our patients on epogen/aranesp.  These 2 articles in the NEJM definitely come close to answering this question.  In the CREATE study 603 patients with a gfr 15-35 were randomized to either a high target hgb (13-15 g/dl) or low (10.5-11.5 g/d)l.  First cardiovascular events were more frequent in the high group although not statistically significant 19.3 vs. 15.6 p=.20)  Also the high group more frequently had to initiate dialysis. This study was terminated early.  In the CHOIR study patients were similarly randomized to  a high group (13.5 g/dL) or a low group (11.3 g/dl) . In the high group there were more endpoints of death, mi, hospitalization chf or cva than in the low group (17.5% vs. 13.5% with a number needed to harm of  29).  Because of these findings the CHOIR study was terminated early.  Both studies showed no difference in quality of life between the two groups.

Together, these 2 articles tell us not to correct these patients to normal, but rather to a target hgb ~11.  Clearly this is important for issues of safety as well as cost.  A single 40,000 unit dose of epogen costs ~ $520.  Another interesting point is that both of these negative trials were published despite being sponsored by industry, something we hope to see more of in the coming years.  As usual for the lead article in the NEJM it made the New York Times, albeit not the front page.

One Response to Epogen and Anemia-Less is More

  1. Neil Shapiro on November 18, 2006 at 6:15 pm

    Yesterday the FDA released an alert warning physicians about these articles.

    http://www.fda.gov/cder/drug/InfoSheets/HCP/RHE_HCP.htm

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